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    Summary
    EudraCT Number:2007-002324-15
    Sponsor's Protocol Code Number:P01092
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-002324-15
    A.3Full title of the trial
    The efficacy and safety of co-trimoxazole therapy in patients with idiopathic interstitial pneumonia
    A.3.2Name or abbreviated title of the trial where available
    TIPAC
    A.4.1Sponsor's protocol code numberP01092
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of East Anglia
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Septrin
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameco-trimoxazole
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 8064902
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCO-TRIMOXAZOLE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number480
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Interstitial Pneumonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10022619
    E.1.2Term Interstitial pulmonary fibrosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy and safety of 6 months therapy with co-trimoxazole 960mg twice daily when added to standard treatment/care in a placebo controlled study of patients with idiopathic interstitial pneumonia
    E.2.2Secondary objectives of the trial
    The secondary objective is to estimate the incremental cost effectiveness of co-trimoxazole plus standard care compared with standard care alone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged greater than 40 years
    2. Female subjects must be of non-childbearing potential, defined as follows
    • postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml
    • females who have had a hysterectomy or bilateral oophorectomy for at least 6 weeks
    3. Able to provide informed consent
    4. A clinical labelled diagnosis of fibrotic idiopathic interstitial pneumonia with HRCT scan features compatible with Usual Interstitial Pneumonia (UIP) or Fibrotic Non-specific Interstitial Pneumonia (NSIP). The following criteria adapted from the ATS/ERS consensus statement will be used for the diagnosis the clinical manifestation of UIP (idiopathic pulmonary fibrosis):
    • Major Criteria (All present)
    o Exclusion of other known causes of interstitial lung disease, such as drug toxicities, environmental exposures, and collagen vascular diseases
    o Abnormal pulmonary function studies that include evidence of restriction with or without impaired gas exchange
    o Bibasal reticular abnormalities with minimal ground glass opacities on HRCT
    • Minor criteria (two out of three features)
    o Insidious onset of otherwise unexplained dyspnoea on exertion
    o Duration of illness 3 months
    o Bibasal inspiratory crackles (dry or ‘‘Velcro-’’ type in quality)
    Patients with clinical diagnosis of non-specific interstitial pneumonia will be entered if fibrotic features are predominant on HRCT. Histology will not be required as an entry criterion.
    5. Patients will have had initial treatment of prednisolone +/- azathioprine, as indicated and described in the current BTS guidelines, without a without a significant response to immunosuppressive therapy that would make the physician doubt the diagnosis of fibrotic idiopathic interstitial pneumonia.
    6. Patients should be on stable treatment regimen for at least 6 weeks. This will include oral prednisolone up to a dose of 20mg per day +/- azathioprine. Patients receiving higher doses of up to 0.5mg/kg may be enrolled in exceptional circumstances after discussion with the principal investigator.
    7. MRC dyspnoea score of 2
    8. A normal serum folate and B12 (to ensure no bone marrow or neurological adverse effects occur with folate therapy to B12 deficient individuals) is required at screening.
    9. Subjects have a 12 lead ECG recording that does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
    E.4Principal exclusion criteria
    1. A secondary cause for pulmonary fibrosis including a diagnosis of asbestosis, drug induced pulmonary fibrosis, collagen vascular disease or other secondary pulmonary fibrosis.
    2. A recognised significant co-existing respiratory disorder.
    3. Long-term oxygen therapy.
    4. Receiving anti-oxidant therapy including acetylcysteine within the last 6 weeks.
    5. A respiratory tract infection within the last 2 months
    6. Overt and persistent heart failure, a myocardial infarction within 3 years, ischaemic heart disease requiring more than one regular therapy or a clinically significant uncontrolled arrhythmia (including Mobitz type II or third degree heart block).
    7. Significant medical, surgical or psychiatric disease that in the opinion of the patients’ attending physician would affect subject safety or influence the study outcome.
    8. Women who are pregnant or are breast-feeding.
    9. Patients receiving immunosuppressant medication (with the exception of prednisolone and azathioprine according to guidelines).
    10. Co-trimoxazole allergy or intolerance and patients receiving medication known to interact with co-trimoxazole.
    11. Untreated folate or B12 deficiency.
    12. Known glucose-6-phosphate dehydrogenase deficiency.
    13. Receipt of an investigational drug or biological agent within the 4 weeks prior to entry in to this study.
    14. Patients with evidence of drug or alcohol misuse
    E.5 End points
    E.5.1Primary end point(s)
    Change in forced vital capacity
    Change in 6 minute walking distance and desaturation
    Change in MRC breathlessness score
    Change in total lung capacity
    Change in total lung diffusing capacity of carbon monoxide
    Change in St Georges Respiratory Questionnaire
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the initial 6 months, the patients physician will decide to either keep the patient on co-trimoxazole therapy or not.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-13
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